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2025/0102(COD)COM(2025)102SANT

Critical Medicines Act

Laying a framework for strengthening the availability and security of supply of critical medicinal products as well as the availability of, and accessibility of, medicinal products of common interest, and amending Regulation (EU) 2024/795

Stage
Council adoption, reached 30 Jun 2026
Procedure
Regulation · Ordinary legislative procedure
Rapporteur
Tomislav Sokol (EPP)
Lead DG
DG SANTE
Commissioner
Olivér Várhelyi
Council configuration
Employment, Social Policy, Health and Consumer Affairs Council
Last activity
14 Jul 2026
Legal basis
TFEU Art. 114; TFEU Art. 294
68 entries · record as of 14 Sept 2026

Where it stands

Latest: Approval of the provisional agreement with the Council by the EP committee responsible, 14 Jul 2026.

Show the earlier record: 48 dates, 12 Mar 2025 to 16 Mar 2026
  1. 12 Mar 2025
    • Adoption of legislative proposal by the Commission
  2. 10 Apr 2025
    • Deliberations in Council working party
  3. 15 Apr 2025
    • Appointment of rapporteur
  4. 23 Apr 2025
    • Decision on procedure
  5. 21 May 2025
    • Referred to committee
  6. 28 May 2025
    • Deliberations in Council working party
  7. 11 Jun 2025
    • Deliberations in Coreper
  8. 18 Jun 2025
    • Appointment of rapporteur
  9. 20 Jun 2025
    • Deliberations in Council
  10. 3 Jul 2025
    • Deliberations in Council working party
  11. 4 Jul 2025
    • Deliberations in Council working party
  12. 6 Jul 2025
    • Feedback on adopted proposal closed: Critical Medicines Act, 74 responses · Commission
  13. 15 Jul 2025
    • Deliberations in Council working party
  14. 18 Jul 2025
    • Committee report tabled
    • EP committee draft report
  15. 23 Jul 2025
    • Deliberations in Council working party
  16. 24 Jul 2025
    • Deliberations in Council working party
  17. 3 Sept 2025
    • Deliberations in Council working party
  18. 4 Sept 2025
    • Consideration / exchange of views
    • Deliberations in Council working party
  19. 10 Sept 2025
    • Deadline for tabling amendments
  20. 25 Sept 2025
    • Deliberations in Council working party
  21. 26 Sept 2025
    • Committee amendments tabled
    • Deliberations in Council working party
    • Tabling of amendments in the EP committee responsible
  22. 8 Oct 2025
    • Deliberations in Council working party
  23. 13 Oct 2025
    • Committee amendments tabled
    • Tabling of amendments in the EP committee responsible
  24. 15 Oct 2025
    • Deliberations in Coreper
  25. 21 Oct 2025
    • Retained as a pending proposal in the Commission work programme · Commission
  26. 27 Oct 2025
    • Deliberations in Council working party
  27. 28 Oct 2025
    • Deliberations in Council working party
  28. 29 Oct 2025
    • Deliberations in Council working party
  29. 3 Nov 2025
    • Deliberations in Council working party
  30. 4 Nov 2025
    • Committee opinion adopted
  31. 6 Nov 2025
    • Deliberations in Council working party
  32. 7 Nov 2025
    • Final opinion sent
  33. 11 Nov 2025
    • Adoption of draft report
    • Committee opinion adopted
  34. 14 Nov 2025
    • Deliberations in Coreper
    • Final opinion sent
  35. 2 Dec 2025
    • General approach by the Council
  36. 15 Dec 2025
    • Committee report adopted
  37. 19 Dec 2025
    • Tabled for plenary
  38. 13 Jan 2026
    • Tabled for plenary
  39. 14 Jan 2026
    • Tabled for plenary
  40. 16 Jan 2026
    • Tabling of a document for EP plenary
  41. 19 Jan 2026
    • Debate in plenary
    • Tabled for plenary
  42. 20 Jan 2026
    • EP decision on amendments to the legislative proposal
    • Plenary vote
    • Plenary amended the proposal
    • Referred back to committee for interinstitutional negotiations
  43. 30 Jan 2026
    • Deliberations in Council working party
  44. 2 Feb 2026
    • Interinstitutional negotiations
  45. 6 Feb 2026
    • Deliberations in Coreper
  46. 5 Mar 2026
    • Deliberations in Council working party
  47. 11 Mar 2026
    • Deliberations in Coreper · Council
  48. 16 Mar 2026
    • Interinstitutional negotiations
  1. 18 Mar 2026
    • Deliberations in Coreper · Council
  2. 28 Apr 2026
    • Deliberations in Council working party · Council
  3. 6 May 2026
    • Deliberations in Coreper · Council
  4. 11 May 2026
    • Interinstitutional negotiations
  5. 13 May 2026
    • Deliberations in Coreper · Council
  6. 16 Jun 2026
    • Deliberations in Council · Council
  7. 30 Jun 2026
    • Endorsement of the provisional agreement by Coreper · Council
  8. 14 Jul 2026
    • Approval of the provisional agreement with the Council by the EP committee responsible · Parliament committee
    • Committee approved the provisional agreement
30 people

Who is on it

The Parliament's rapporteurs, shadow rapporteurs and opinion rapporteurs currently on this file.

RoleNameGroupCountryCommittee
RapporteurTomislav SokolEPPHRSANT
Shadow rapporteurAurelijus VerygaECRLTSANT
Shadow rapporteurCatarina MartinsThe LeftPTSANT
Shadow rapporteurChristine AndersonESNDESANT
Shadow rapporteurOndřej KnotekPfECZSANT
Shadow rapporteurTiemo WölkenS&DDESANT
Shadow rapporteurTilly MetzGreens/EFALUSANT
Shadow rapporteurVlad Vasile-voiculescuRenewROSANT
Rapporteur for opinionMichele PicaroECRITENVI
Rapporteur for opinionMarion WalsmannEPPDEIMCO
Rapporteur for opinionOliver SchenkEPPDEITRE
Shadow rapporteur for opinionAndrás Tivadar KuljaEPPHU
Shadow rapporteur for opinionAndreas GLÜCKRenewDE
Shadow rapporteur for opinionAnthony SmithThe LeftFR
Shadow rapporteur for opinionBilly KelleherRenewIE
Shadow rapporteur for opinionChristel SchaldemoseS&DDK
Shadow rapporteur for opinionChristine AndersonESNDE
Shadow rapporteur for opinionFrancesco TorselliECRIT
Shadow rapporteur for opinionGaetano Pedulla'The LeftIT
Shadow rapporteur for opinionMariateresa VivaldiniECRIT
Shadow rapporteur for opinionMohammed ChahimS&DNL
Shadow rapporteur for opinionNicolae ȘtefănuțăGreens/EFARO
Shadow rapporteur for opinionOndřej KnotekPfECZ
Shadow rapporteur for opinionSaskia BricmontGreens/EFABE
Shadow rapporteur for opinionTiemo WölkenS&DDE
Shadow rapporteur for opinionTilly MetzGreens/EFALU
Shadow rapporteur for opinionValentina PalmisanoThe LeftIT
Shadow rapporteur for opinionVeronika Cifrová OstrihoňováRenewSK
Shadow rapporteur for opinionViktória FerencPfEHU
Shadow rapporteur for opinionVirginie JoronPfEFR
1,794 amendments

Amendments

Tabled between 5 Sept 2025 and 13 Oct 2025. The texts are in the amendment documents below.

By committee

  • SANT1,144
  • ITRE353
  • IMCO190
  • ENVI107

By author

  • Pierre Jouvet153
  • Tilly Metz138
  • Romana Jerković129
  • Aleksandar Nikolic121
  • Nikos Papandreou117
  • Tiemo Wölken114
  • Vytenis Povilas Andriukaitis106
  • Marta Temido105
  • Ondřej Knotek101
  • Estelle Ceulemans99
Show 20 more authors
  • Günther Sidl99
  • Raffaele Topo99
  • Marie-Luce BRASIER-CLAIN98
  • Ondřej Krutílek94
  • Veronika Cifrová Ostrihoňová87
  • Margarita de la Pisa Carrión84
  • Laurent Castillo82
  • Anthony Smith76
  • Tomáš Kubín74
  • Nicolae ȘTEFĂNUȚĂ67
  • Christophe Clergeau66
  • Mathilde Androuët63
  • Vlad VASILE-VOICULESCU59
  • Aurelijus Veryga58
  • Viktória Ferenc58
  • Nicolás González Casares56
  • Valérie Deloge55
  • Francesco Torselli53
  • Mariateresa Vivaldini48
  • Olivier Chastel46

Amendments each member tabled or co-signed.

By article

  • Article 18 – paragraph 133
  • Article 27 – paragraph 126
  • Article 1 – paragraph 124
  • Article 18 – paragraph 223
  • Article 20 – paragraph 120
  • Article 19 – paragraph 119
  • Article 20 – paragraph 218
  • Article 5 – paragraph 1 – introductory part18
  • Recital 1218
  • Article 15 – paragraph 117
Show 20 more provisions
  • Article 18 – paragraph 317
  • Article 20 – paragraph 2 a (new)17
  • Article 25 – paragraph 217
  • Article 4 – paragraph 217
  • Article 5 – paragraph 1 – point d a (new)17
  • Article 16 – paragraph 115
  • Recital 3715
  • Article 26 – paragraph 2 – point d a (new)14
  • Article 3 – paragraph 1 – point 514
  • Article 5 – paragraph 1 – point b14
  • Article 7 – paragraph 214
  • Recital 2414
  • Recital 4 a (new)14
  • Article 18 – paragraph 413
  • Article 18 – paragraph 513
  • Article 25 – paragraph 313
  • Article 5 – paragraph 1 – point d13
  • Article 15 – paragraph 212
  • Article 16 – paragraph 1 a (new)12
  • Article 16 – paragraph 2 a (new)12

Covers 503 of the 1,794 amendments.

10 documents

Documents

Newest first. Each opens at its source.

1 consultation

Consultations on it

The Commission's Have Your Say consultations linked to this file. Each title opens on the Commission's portal.

ConsultationFeedback received
199

Summary

Generated

The Critical Medicines Act establishes a binding framework to strengthen availability and security of supply for critical medicinal products, and improve access to products of common interest. It amends Regulation (EU) 2024/795, focusing on EU production, public procurement, and supply chain resilience.

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Sources: EP Legislative Observatory · EU Law Tracker. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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